Dep Director Principle Science US-Swiftwater, PA
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Principal Scientist Quality Control Analytical Support
Vaccine Industrial Affairs, Swiftwater, Pennsylvania, USA
Who We Are
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year against 20 infectious diseases, making it possible to immunize more than 500 million people across the globe. Industrial Operations (IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing sites in the USA, continues to develop its manufacturing assets for existing and new vaccines and biopharmaceuticals.
The Principal Scientist in Quality Control Analytical Support will provide technical support to the Quality Control laboratories while strictly adhering to Sanofi Pasteur policies and procedures and cGMPs. The candidate filling this position will
work to insure tasks are completed in a timely and compliant manner. The candidate will serve as a department subject matter expert for HPLC, wet chemistry, LC-MS, ICP-MS, and/or other biochemical testing methodologies. The candidate will perform method validation and transfer activities for Quality Control methods. The candidate will serve as a subject matter expert in HPLC. The candidate will interact with health authorities during inspections. The candidate is required to complete Safety and Compliance training and associated training modules.
- Method Validation / Method Transfer: Performs current tasks by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), sanofi pasteur policies and procedures and safety procedures. Executes and approves protocols and QC testing instructions as defined by management to meet demands of Production, Stability, and Project Independent Demand requirements. Timely completion of required paperwork and documentation as required.
- Laboratory Support: Serves as a subject matter expert supporting the QC laboratories for HPLC, wet chemistry, LC-MS, ICP-MS, and/or other biochemical testing methodologies supporting both licensed products and new vaccine projects.
- Training: Attends/Contributes to scheduled team meetings, department meetings, and safety meetings. Document review. Safety and compliance training. Module/Task training as assigned and offer suggestions for improvement. Professional/Technical development training on/ off-site as assigned. Train others on any processes, procedures, tasks, and equipment they are proficient on.
- Compliance: Demonstrate proficiency in use and knowledge of change controls, CAPAs, validation deviations, and the QA deviation system. Serves as a subject matter expert for HPLC during health authority inspections. Notifies management of any deviations or issues and initiates incident investigations as required. Perform initial deviation investigations through analyst interview and equipment inventory. Develop a working knowledge of appropriate compendia and/or regulatory guidance’s. All other assigned duties.
Who You Are
You are inspired and driven by sanofi pasteur’s IO mission to improve worldwide human health. You would fit in well with our sanofi values of innovation, solidarity, confidence, respect and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
Education and experience
- Excellent organizational, written, interpersonal, and teamwork abilities.
- Excellent working knowledge of cGMPs (US, Canada, Japan, Europe).
- Experience in QC testing of marketed products and/or clinical product is required.
- Experience with HPLC, wet chemistry, LC-MS and/or ICP-MS is required
- Experience in method validation, method transfer, and design of comparability studies is required.
- Experience with Health Authority inspections is beneficial.
- Experience in SAP, LabWare, & Trackwise is beneficial.
- Detail Oriented
- BA/BS in life science and a minimum of 10 years of relevant experience in a cGMP
- controlled/pharmaceutical industry or testing laboratory.
- MS in life sciences and a minimum of 8 years of relevant experience in a cGMP controlled/pharmaceutical industry or testing laboratory.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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